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Suppliers and packagers for caprelsa
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caprelsa
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Genzyme Corp | CAPRELSA | vandetanib | TABLET;ORAL | 022405 | NDA | Genzyme Corporation | 58468-7820-3 | 1 BOTTLE, PLASTIC in 1 CARTON (58468-7820-3) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 2011-07-25 |
| Genzyme Corp | CAPRELSA | vandetanib | TABLET;ORAL | 022405 | NDA | Genzyme Corporation | 58468-7840-3 | 1 BOTTLE, PLASTIC in 1 CARTON (58468-7840-3) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 2011-07-25 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: CAPRELSA (Vandetanib)
Introduction
CAPRELSA (Vandetanib) is an orally administered targeted therapy developed primarily for the treatment of thyroid cancer, specifically symptomatic or metastatic medullary thyroid carcinoma (MTC). As a tyrosine kinase inhibitor, Vandetanib inhibits multiple signaling pathways involved in tumor growth and angiogenesis, notably RET, VEGFR, and EGFR. The drug’s complex synthesis, stringent manufacturing requirements, and high standards for quality underscore the importance of a robust supply chain comprising reliable suppliers across the pharmaceutical manufacturing spectrum.
Manufacturers and Supply Chain Overview
Vandetanib (CAPRELSA) was developed and commercialized by AstraZeneca. The overall supply chain for this branded pharmaceutical involves multiple key suppliers spanning active pharmaceutical ingredient (API) manufacturing, formulation, packaging, and distribution. While AstraZeneca maintains control over pivotal manufacturing processes, the globalized nature of pharmaceutical production means various suppliers contribute components and services to ensure consistent supply.
Active Pharmaceutical Ingredient (API) Suppliers
1. API Production and Raw Material Sourcing
Api manufacturing for Vandetanib is a highly specialized process due to its complex chemical structure and strict purity standards dictated by regulatory agencies such as the FDA and EMA. The active pharmaceutical ingredient in CAPRELSA is produced by selected chemical synthesis facilities, often operated by Contract Manufacturing Organizations (CMOs) or large pharmaceutical ingredient suppliers.
Leading API Suppliers:
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Samsung Biologics & Samsung Biotech (South Korea)
While primarily known for biologics, Samsung has expanded into chemical synthesis and API manufacturing, including compounds similar to Vandetanib, owing to their large-scale facilities and stringent quality controls. -
Jiashuo Pharmaceutical (China)
A growing API manufacturer specializing in complex small-molecule APIs, with adherence to Good Manufacturing Practice (GMP). -
Liangfeng Pharmaceutical (China)
Specialist in chemotherapeutic APIs, Liangfeng has the capacity to produce small-molecule kinase inhibitors, including APIs similar to Vandetanib. -
CordenPharma (Germany)
Part of the International Chemical Investors Group, CordenPharma offers global API synthesis, including complex oncology agents, with facilities compliant with GMP. -
BASF (Germany)
Major chemical supplier with capabilities for custom synthesis of complex intermediates used in API manufacturing; BASF produces key synthetic intermediates under strict GMP conditions.
It’s crucial to recognize that AstraZeneca’s proprietary API synthesis route for Vandetanib is exclusive, involving specific intermediates and catalysts, often supplied by a combination of these manufacturers under confidentiality agreements.
Excipients and Formulation Components Suppliers
While API suppliers are the backbone, excipients and formulation materials also play a critical role.
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Evonik Industries (Germany)
Supplies pharmaceutical-grade excipients that may be used in tablet formulation. -
JRS Pharma (Germany)
Provides disintegrants and binders complying with pharmaceutical standards for oral solid dosage forms. -
Capsugel (United States, part of Lonza)
Provides capsules and coating materials for oral delivery.
Manufacturing and Packaging
Contract Manufacturing Organizations (CMOs):
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Patheon (Thermo Fisher Scientific, USA)
Provides formulation development and manufacturing services, including tablet compression and coating. -
Catalent Pharma Solutions (USA)
Offers development, formulation, and high-volume manufacturing capacities. -
Bulldog Pharma (UK)
Responsible for small-molecule drug synthesis, formulation, and final packaging.
Packaging Suppliers:
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WestRock (USA)
Supplies primary packaging materials conforming to pharmaceutical standards. -
Nestlé Healthcare Nutrition (Switzerland)
Provides tamper-evident, child-resistant packaging solutions.
Supply Chain Challenges and Considerations
Regulatory Stringency:
API and excipient suppliers must maintain GMP compliance, with ongoing audits from regulatory bodies. The complexity of Vandetanib’s synthesis amplifies the importance of stable, high-quality suppliers to prevent disruptions.
Supply Chain Risks:
Dependency on Chinese and Indian suppliers, especially for raw materials and intermediates, exposes manufacturers to geopolitical risks, trade restrictions, and quality control issues. AstraZeneca mitigates this through multiple sourcing and quality agreements.
Intellectual Property and Confidentiality:
The proprietary synthesis route necessitates strict confidentiality agreements with suppliers, often restricting public disclosure of precise sourcing details.
Market Dynamics and Supply Chain Trends
The global market for oncology drugs like Vandetanib reflects increasing demand amid rising thyroid cancer incidence rates. As a result, supply chain resilience has become paramount, prompting pharmaceutical companies to diversify supplier bases, develop secondary sourcing strategies, and invest in supply chain transparency.
Recent trends emphasize:
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Shift Towards Asian API Suppliers:
Asia, notably China and India, remains a dominant hub owing to cost advantages and capacity, prompting efforts to ensure quality standards. -
Vertical Integration & Strategic Partnerships:
AstraZeneca has engaged in strategic collaborations and licensing agreements to stabilize supply and reduce reliance on single-source suppliers. -
Enhanced Regulatory Oversight:
As countries tighten GMP inspections and enforce stricter licensing, suppliers are required to maintain rigorous compliance, impacting procurement strategies.
Conclusion
The supply chain for CAPRELSA involves a complex network of specialized API manufacturers, excipient suppliers, and contract manufacturers. Key players include global leaders such as CordenPharma, BASF, and regional suppliers from China and India. Ensuring the uninterrupted supply of Vandetanib hinges on rigorous quality control, diversified sourcing, and a comprehensive understanding of the geopolitical and regulatory environment affecting these suppliers.
Key Takeaways
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Diverse Supplier Base:
AstraZeneca and generic manufacturers depend on a mix of regional and global suppliers, emphasizing supply chain resilience. -
Regulatory Compliance:
Suppliers must meet stringent GMP standards; deviations pose risks to continuity and quality. -
Geopolitical Risks:
Heavy reliance on Asian API producers necessitates risk mitigation strategies against trade disruptions. -
Innovation and Collaboration:
Strategic partnerships with CMOs help ensure stable supply and safeguard proprietary synthesis routes. -
Forward-Looking Strategies:
Industry trends include increasing transparency, diversification, and investment in quality assurance processes.
FAQs
1. Who are the main suppliers of Vandetanib API?
Leading API manufacturers include CordenPharma (Germany), BASF (Germany), and Chinese firms like Liangfeng Pharmaceutical. AstraZeneca maintains proprietary sourcing agreements to ensure quality and supply consistency.
2. Are there alternative suppliers for CAPRELSA in case of disruption?
Yes. The global pharmaceutical supply chain incorporates secondary and tertiary suppliers, especially in China and India, to mitigate disruptions. Regulatory standards and quality assessments are critical in qualifying these alternative sources.
3. How does AstraZeneca control its API supply chain?
AstraZeneca employs strategic agreements with GMP-compliant manufacturers, audits suppliers regularly, and diversifies sourcing to prevent dependency on single sources.
4. What is the impact of geopolitical tensions on Vandetanib supply?
Geopolitical issues, especially trade restrictions or sanctions involving China or India, can affect raw material availability. Companies are diversifying supply sources to reduce vulnerability.
5. How do regulatory standards influence supplier selection?
Suppliers must adhere to GMP/GLP regulations enforced by agencies such as FDA, EMA, and local regulators. Continuous compliance is necessary for continued supply and market authorization.
Sources
[1] AstraZeneca. “CAPRELSA (Vandetanib) Prescribing Information,” 2023.
[2] U.S. Food and Drug Administration. “Generic Drug Approvals and Patent Data,” 2023.
[3] CordenPharma. “API Manufacturing Capabilities,” 2023.
[4] BASF. “Custom Synthesis for Pharmaceutical Applications,” 2023.
[5] Industry Reports on API Supply Chains, 2022.
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